- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134896
Visual Performance With Spatial Light Modulator
Visual Performance After Optically Correcting the Eye's Aberration With a Spatial Light Modulator
Eye's aberrations have been known to degrade human visual performance and the visual performance is significantly improved when correcting the aberrations in the central visual field. However, how the aberration correction affects the peripheral visual performance is not well understood. Moreover, how central and peripheral vision interacts remains unclear.
To conduct the study, we will use an adaptive optics vision simulator equipped with a Shack-Hartmann wavefront sensor and a spatial light modulator (see details in procedures section of the protocol). This system is capable of noninvasively controlling the eye's optical quality and evaluating visual performance simultaneously over a wide area of visual space. This study provides insights into the visual performance in the periphery visual field, and interaction between central and peripheral visual fields.
The goal of this study is to evaluate the visual performance at central and peripheral visual fields after correcting the ocular aberrations. An optical system equipped with a liquid crystal spatial light modulator will be used to achieve this goal non-invasively.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Geunyoung Yoon, PhD
- Phone Number: 7137437860
- Email: gyoon2@central.uh.edu
Study Contact Backup
- Name: Jiakai Lyu, MS
- Phone Number: 6262953929
- Email: jlyu@central.uh.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is between the ages of 18 and 60.
- Has normal corneas i.e. no corneal infections, no systemic pink eye, no clinically significant dry eye, and no corneal dystrophies.
- Has refractive errors less than +/- 10.0 Diopters in both eyes.
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Adults between the ages of 18-60 who are unable to give informed consent
- Individuals below 18 years old
- Individuals above the age of 60
- Pregnant women (self-reporting, hormonal changes may alter the refractive status of the eye)
- Prisoners
- Students for whom you have direct access to/influence on grades
- People who do not understand or speak English
- Has clinically significant dry eye.
- Has clinically significant cataract.
- Has spherical refractive error that exceeds the limits outlined above.
- Is unable to hold his or her head steady for the duration of study measurements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: normal healthy group
Spatial light modulator
|
This device compensates for the eye's optical imperfections (aberrations) at the foveal and peripheral retina.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: up to 6 separate sessions (each session taking up to 2 hours)
|
Snellen "Tumbling E" method will be used to determine the smallest letter that a subject can see.
|
up to 6 separate sessions (each session taking up to 2 hours)
|
Contrast sensitivity
Time Frame: up to 6 separate sessions (each session taking up to 2 hours)
|
Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see
|
up to 6 separate sessions (each session taking up to 2 hours)
|
Contrast perception
Time Frame: up to 6 separate sessions (each session taking up to 2 hours)
|
Light and dark sinusoidal stripes (Gabor gratings) will used to determine differences in contrast perceived by the central and peripheral visual system
|
up to 6 separate sessions (each session taking up to 2 hours)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00003209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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